CSL Limited

Last updated

CSL Limited
Type Public
Industry Biotechnology
Founded1916 (Federal government department), 1994 (privatised)
Headquarters Parkville, Melbourne, Victoria, Australia (Global), [1]
Key people
Paul McKenzie (CEO)
Products blood plasma, vaccines, antivenom, other laboratory and medical products
Revenue US$10.61 billion (2021)) [2]
Increase2.svg US$1.919 billion (2021) [2]
Number of employees
30,000 person (2021) [2]
Divisions
  • CSL Behring
  • CSL Seqirus
  • CSL Plasma
  • CSL Vifor
Website www.csl.com

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. CSL's product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. [3] The company was established in 1916 as Commonwealth Serum Laboratories and was wholly owned by the Australian federal government until its privatisation in 1994.

Contents

History

Origin and Penfold directorship

CSL was founded in 1916 as Commonwealth Serum Laboratories, an Australian government body focused on vaccine manufacture. [4] Under the first director, William Penfold, [5] CSL commenced operation in the vacant Walter and Eliza Hall Institute building at the Royal Melbourne Hospital in 1918 before moving to its purpose-built Parkville premises in the following year.

Morgan directorship

After ongoing disputes with the Department of Health and its director-general John Cumpston, Penfold resigned in 1927 and was replaced by Frederic Morgan. [6] Soon after Morgan's appointment, CSL was drawn into a serious public health disaster when a batch of its diphtheria toxin-antitoxin was implicated in the deaths of twelve children in what became known as the Bundaberg tragedy of 1928. Although CSL's manufacturing processes were absolved, its labelling procedures were seen to be in error, leading to an enduring focus on the highest standards across the facility's production. [7]

Antivenene research and production

In 1928, CSL also became involved in antivenene (antivenom) manufacture in conjunction with the snake venom research undertaken by Charles Kellaway at the Hall Institute. [8] This led to the successful clinical testing of antivenene against tiger snake Notechis scutatus bite in 1930 and its commercial release in 1931.

In 1934, the research on snake venoms was transferred from the Hall Institute to CSL under the direction of former snake showman and herpetologist Tom "Pambo" Eades. This represented the initiation of research at the laboratories – an outcome its directors had been seeking for over a decade. The relationship with the Hall Institute continued until World War II, particularly via joint projects on viral diseases including polio and influenza coordinated by Frank Macfarlane Burnet and Esmond "Bill" Keogh. Keogh played an important role in the establishment of penicillin production at CSL in 1944 – a critical wartime achievement. [9]

Plasma fractionation and Wiener directorship

In 1952, operation commenced plasma fractionation. [10] Thereafter the range of antivenoms increased, including those against other snake species such as death adder ( Acanthophis antarcticus ) and the taipan ( Oxyuranus scutellatus ), plus spiders including the redback ( Latrodectus hasselti ) and – after much difficulty – the Sydney funnel-web ( Atrax robustus ). Much of this work, including the introduction in 1962 of a polyvalent antivenom against all of the major terrestrial Australian snakes, occurred under the direction of Saul Wiener, while from 1966 until the mid-1990s, venom research was coordinated by the eccentric but dedicated Struan Sutherland, who in 1979 released new guidelines for snakebite first aid, [11] and a new test for snakebites that would identify which snake had envenomated the victim. [12]

Other major achievements of CSL include: [13]

Privatisation

In 1994, the Commonwealth facility was privatised by the Keating government as CSL Ltd. and was publicly listed and traded on the Australian Securities Exchange. The company completed an initial public offering in June 1994 at A$2.30 per share (76.7c adjusted for split). CSL stock is part of the S&P/ASX 20 Index. [15]

Acquisition of ZLB Bioplasma AG and Aventis Behring

In 2000, CSL doubled its size through the purchase of a Swiss plasma company, the Bern-based ZLB Bioplasma AG. [16] In 2004, during a period of plasma oversupply, the company expanded again with the purchase of the German medical company Aventis Behring. [17] The company was the second Australian public company to have reached a share price of over $100 per share. [18]

Acquisition and merging of Novartis

In October 2014, Novartis announced its intention to sell its influenza vaccine business, including its development pipeline, to CSL for $275 million. CSL merged it into its BioCSL operation. [19]

In November 2015, BioCSL rebranded the combined business with Novartis Influenza Vaccines as Seqirus [Sek-eer-us], creating the world's second-largest influenza vaccine company. [20]

In August 2017, the business announced it would acquire Calimmune and its stem cell therapy platform. [21]

Completed in 2018, Seqirus's Holly Spring, NC, the plant was funded with $59 million from the U.S. government. [22]

in June 2020, CSL announced it would exercise its right to acquire Vitaeris. [23]

In December 2021, the business announced it would acquire Swiss drugmaker, Vifor Pharma AG, for $11.7 billion. [24]

In August 2022, CSL rebranded all of its divisions to start with the CSL name. Therefore, the divisions became CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor.

Acquisition history

CSL Limited acquisitions
  • CSL Limited(Founded 1916 as Commonwealth Serum Laboratories)
    • ZLB Behring
      • ZLB Bioplasma AG (Acq 2000)
      • Aventis Behring (Acq 2004)
      • Vifor Pharma (Acq 2021)
    • Seqirus (Merged 2014)
      • BioCSL
      • Novartis Influenza Vaccines div.
    • Calimmune (Acq 2017)
    • Vitaeris (Acq 2020)
CSL's global headquarters building in Parkville, Victoria CSL Global Headquarters, Parkville, Victoria, Australia.jpg
CSL's global headquarters building in Parkville, Victoria

Locations

The company's headquarters remain in Parkville, Victoria, an inner suburb of Melbourne, and has offices and laboratory space in Sydney.

CSL Behring is headquartered in King of Prussia, USA and it has manufacturing operations and R&D laboratories in Broadmeadows, Victoria, the Swiss city of Bern, in Marburg in Germany, and Kankakee, USA.

Seqirus has its headquarters in Maidenhead and has production facilities in Holly Springs, US, Liverpool, UK, and Parkville, Victoria

Vaccines

A/H1N1 2009 pandemic

CSL's vaccine for swine flu, the world's first, was approved in September 2009 for use by people over age 10. [25] The federal government ordered 21 million doses of vaccine for Australians. [26] CSL also provided vaccines for customers in Singapore and the US.

On 28 September 2010, the Australian Therapeutic Goods Administration (TGA) conducted an analysis of febrile convulsions following immunisation in children following monovalent pandemic H1N1 vaccine (Panvax/Panvax Junior, CSL). [27]

A paper published in the Medical Journal of Australia provides a possible reason for CSL's 2010 flu vaccine causing febrile convulsions in children. The authors hypothesise that suboptimal use of the detergent called deoxycholate – used in the manufacturing process by CSL (one of the few vaccine manufacturers that use it) – to split the flu virus from its membrane may be at fault. [28]

COVID-19 pandemic

On 7 September 2020, CSL signed agreements with the Australian government to supply the University of Queensland vaccine (V451) and to manufacture (with AstraZeneca) the Oxford University vaccine (AZD1222), which would yield nearly 85 million doses for Australians. The agreement was contingent on the future success of clinical trials of these vaccines. Most of the manufacture would occur in Melbourne, Australia. [29] [30]

On 11 December 2020, after a high percentage of the University of Queensland vaccine trial participants returned "false positive" results for HIV, it was decided that vaccine development will not proceed to Phase 2/3 trials. [31]

On 23 March 2021, the Therapeutic Goods Administration provisionally approved the first batches, numbering 832,000 doses, of the Oxford–AstraZeneca COVID-19 vaccine manufactured by CSL in its plant in Broadmeadows, Victoria. The Australian Government has contracted CSL to produce 50 million doses of the vaccine. [32]

Divisions

CSL Limited's products can be separated by company division. Some of the key products produced by each division, have included:

Seqirus (bioCSL)

Vaccines: [33]

Antivenoms: (Australia) [34]

CSL Behring (Australia)

[35]

CSL Behring

Immunology: [36]

Coagulation/Bleeding Disorders:

Pulmonary:

Critical Care:

Wound Healing:

Product availability varies from country to country, depending on registration status.

Honours

In 2011, the company received the Minister's Award for Outstanding Equal Employment Opportunities Initiative for their Thinking Kids Children's Centre. [37]

See also

Related Research Articles

<span class="mw-page-title-main">Intramuscular injection</span> Medical injection into a muscle

Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have larger and more numerous blood vessels than subcutaneous tissue, leading to faster absorption than subcutaneous or intradermal injections. Medication administered via intramuscular injection is not subject to the first-pass metabolism effect which affects oral medications.

<span class="mw-page-title-main">Antivenom</span> Medical treatment for venomous bites and stings

Antivenom, also known as antivenin, venom antiserum, and antivenom immunoglobulin, is a specific treatment for envenomation. It is composed of antibodies and used to treat certain venomous bites and stings. Antivenoms are recommended only if there is significant toxicity or a high risk of toxicity. The specific antivenom needed depends on the species involved. It is given by injection.

In immunology, antiserum is a blood serum containing antibodies that is used to spread passive immunity to many diseases via blood donation (plasmapheresis). For example, convalescent serum, passive antibody transfusion from a previous human survivor, used to be the only known effective treatment for ebola infection with a high success rate of 7 out of 8 patients surviving.

<span class="mw-page-title-main">Factor X</span> Mammalian protein found in Homo sapiens

Factor X, also known by the eponym Stuart–Prower factor, is an enzyme of the coagulation cascade. It is a serine endopeptidase. Factor X is synthesized in the liver and requires vitamin K for its synthesis.

<span class="mw-page-title-main">H5N1 vaccine clinical trials</span> Clinical trials of influenza vaccine

H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.

Prothrombin complex concentrate (PCC), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. Some versions also contain factor VII. It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available. It may also be used for reversal of warfarin therapy. It is given by slow injection into a vein.

Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.

<span class="mw-page-title-main">CSL Behring</span>

CSL Behring is a biopharmaceutical company, manufacturing plasma-derived, and recombination therapeutic products. The company is a combination of Behringwerke, founded in 1904 in Marburg, Germany by Emil von Behring, and the Commonwealth Serum Laboratories (CSL), established in Australia in 1916 to provide vaccines to the people of Australia, as well as other companies acquired since 2004.

<span class="mw-page-title-main">Diphtheria vaccine</span> Vaccine against diphtheria

Diphtheria vaccine is a toxoid vaccine against diphtheria, an illness caused by Corynebacterium diphtheriae. Its use has resulted in a more than 90% decrease in number of cases globally between 1980 and 2000. The first dose is recommended at six weeks of age with two additional doses four weeks apart, after which it is about 95% effective during childhood. Three further doses are recommended during childhood. It is unclear if further doses later in life are needed.

Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B and is used for the treatment of acute exposure to HBsAg.

<span class="mw-page-title-main">H5N1 vaccine</span> Vaccine designed to provide immunity against H5N1 influenza

A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.

Rabies immunoglobulin (RIG) is a medication made up of antibodies against the rabies virus. It is used to prevent rabies following exposure. It is given after the wound is cleaned with soap and water or povidone-iodine and is followed by a course of rabies vaccine. It is given by injection into the site of the wound and into a muscle. It is not needed in people who have been previously vaccinated against rabies.

Immunoglobulin therapy is the use of a mixture of antibodies to treat several health conditions. These conditions include primary immunodeficiency, immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, certain cases of HIV/AIDS and measles, Guillain-Barré syndrome, and certain other infections when a more specific immunoglobulin is not available. Depending on the formulation it can be given by injection into muscle, a vein, or under the skin. The effects last a few weeks.

Kenneth R. Slater was an Australian engineer and herpetologist. Slater's deliveries of snake venom were instrumental in the development of antivenom for several species.

Ram Chandra was a snake showman in Australia. He was known as Australia's "taipan man" and for his work in extracting snake venom to create antivenoms.

<span class="mw-page-title-main">Vaccine ingredients</span> Ingredients used in a vaccine dose

A vaccine dose contains many ingredients very little of which is the active ingredient, the immunogen. A single dose may have merely nanograms of virus particles, or micrograms of bacterial polysaccharides. A vaccine injection, oral drops or nasal spray is mostly water. Other ingredients are added to boost the immune response, to ensure safety or help with storage, and a tiny amount of material is left-over from the manufacturing process. Very rarely, these materials can cause an allergic reaction in people who are very sensitive to them.

References

  1. ↑ "Annual Report 2019" (PDF). CSL Limited. 2019.
  2. 1 2 3 "CSL Annual Report 2021/22". CSL Limited. April 2022. Retrieved 29 March 2023.
  3. ↑ "CSL LTD (CSL:ASX): Stock Quote & Company Profile". Bloomberg Businessweek. Archived from the original on 18 January 2013. Retrieved 13 August 2012.
  4. ↑ "Trove". trove.nla.gov.au. Retrieved 22 September 2020.
  5. ↑ Robin, A. De Q. Penfold, William James (1875–1941). Canberra: National Centre of Biography, Australian National University.
  6. ↑ Egan, Bryan, "Morgan, Frederick Grantley (1891–1969)", Australian Dictionary of Biography, Canberra: National Centre of Biography, Australian National University, retrieved 22 September 2020
  7. ↑ "BUNDABERG TRAGEDY, Daily Examiner". 14 June 1928. p. 3 – via Trove.
  8. ↑ Hobbins, Peter G.; Winkel, Kenneth D. (3 December 2007). "The forgotten successes and sacrifices of Charles Kellaway, director of the Walter and Eliza Hall Institute, 1923–1944". The Medical Journal of Australia. 187 (11): 645–648. doi:10.5694/j.1326-5377.2007.tb01457.x. PMID   18072902. S2CID   23444263.
  9. ↑ Gardiner, Lyndsay; Serle, Geoffrey (2000). "Keogh, Esmond Venner (Bill) (1895–1970)". Australian Dictionary of Biography. National Centre of Biography, Australian National University. 15.
  10. ↑ Flood, Phillip; Wills, Peter; Lawler, Peter; Ryan, Graeme; Rickard, Kevin A. (2006). Review of Australia's Plasma Fractionation Arrangements (PDF). ISBN   1-74186-121-7.
  11. ↑ "SAFER FIRST AID, Papua New Guinea Post-Courier". 18 April 1979. p. 11 – via Trove.
  12. ↑ "New test for snake bites, The Canberra Times". 30 October 1979. p. 14 – via Trove.
  13. ↑ Tasker, Sarah-Jane (23 April 2016). "Blood, sweat and tears of the CSL century". The Australian.
  14. ↑ "A global solution to reducing cervical cancer" (PDF). Uniquest commercialisation stories. The University of Queensland. Retrieved 29 April 2016.
  15. ↑ "CSL Limited". Australian Securities Exchange . Retrieved 7 February 2020.
  16. ↑ Dow Jones Newswires (9 December 2003). "Australia's CSL Agrees to Acquire Aventis Unit for up to $925 Million". The Wall Street Journal. Retrieved 22 February 2021. … this deal eclipses the A$1 billion (US$740.2 million) CSL spent in 2000 to buy ZLB Bioplasma from the Swiss Red Cross.
  17. ↑ "Aventis disposes of Behring unit with $925M sale to Australia's CSL –". thepharmaletter.com. The Pharma Letter. 15 December 2003. Archived from the original on 23 September 2021. Retrieved 22 February 2021. … Aventis says that it has agreed to sell its Aventis Behring blood products business to Australia's CSL …
  18. ↑ "CSL bursts through the $100 barrier". Quest Asset Partners. 4 August 2015. Archived from the original on 28 February 2016. Retrieved 22 February 2021.
  19. ↑ Phillipidis, Alex (27 October 2014). "Novartis Selling Flu Vaccine Business to CSL for $275M". Genetic Engineering & Biotechnology News. Retrieved 22 May 2020.
  20. ↑ Sequirus Commonwealth Serum Laboratories
  21. ↑ "CSL Behring Acquires Biotech Company Calimmune and its Proprietary Stem Cell Gene Therapy Platform" (Press release). CSL. 6 August 2017. Retrieved 15 December 2021.
  22. ↑ Willman, David (15 March 2020). "Federal vaccine development sites ill-suited to counter covid-19 epidemic". The Washington Post. Retrieved 15 March 2020.
  23. ↑ "CSL to Acquire Biotech Company Vitaeris" (Press release). CSL. 6 September 2020. Retrieved 15 December 2021.
  24. ↑ Nainan, Nikhil; Koltrowitz, Silke; Murdoch, Scott (14 December 2021). "Australia's CSL to buy Swiss drugmaker Vifor for $11.7 bln". Reuters. Retrieved 15 December 2021.
  25. ↑ "Panvax H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration". Melbourne, Australia: CSL Limited. 18 September 2009. Archived from the original on 25 September 2009. Retrieved 26 September 2009. CSL Biotherapies, a subsidiary of CSL Limited, Australia's leading biopharmaceutical company, can today confirm that its vaccine against the pandemic (H1N1) 2009 influenza or 'swine flu' has been approved registration for use in people aged 10 years and over.
  26. ↑ Tran, Mark (22 July 2009). "First human trials of swine flu vaccine begin in Australia". The Guardian. ISSN   0261-3077 . Retrieved 7 September 2020.
  27. ↑ Administration, Australian Government Department of Health Therapeutic Goods (28 September 2010). "Analysis of febrile convulsions following immunisation in children following monovalent pandemic H1N1 vaccine (Panvax/Panvax Junior, CSL)". Therapeutic Goods Administration (TGA). Retrieved 25 July 2022.
  28. ↑ Kelly, Heath A; Skowronski, Danuta M; De Serres, Gaston; Effler, Paul V (19 September 2011). "Adverse events associated with 2010 CSL and other inactivated influenza vaccines". The Medical Journal of Australia. 195 (6): 318–320. doi:10.5694/mja11.10941. PMID   21929484. S2CID   9389146.
  29. ↑ "CSL to manufacture and supply University of Queensland and Oxford University vaccine candidates for Australia". csl.com. 7 September 2020. Retrieved 7 September 2020.
  30. ↑ "Australia secures onshore manufacturing agreements for two COVID-19 vaccines | Prime Minister of Australia". pm.gov.au. 7 September 2020. Archived from the original on 7 September 2020. Retrieved 7 September 2020.
  31. ↑ "Update on The University of Queensland COVID-19 vaccine" (PDF). CSL Limited. Archived (PDF) from the original on 11 December 2020.
  32. ↑ "National medical regulator approves 800,000 Australian-made doses of AstraZeneca vaccine". Australian Broadcasting Corporation. 23 March 2021. Retrieved 9 April 2021.
  33. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 "Products". Seqirus. 6 December 2018. Retrieved 5 February 2020.
  34. 1 2 "Products". Seqirus. Australia. Retrieved 9 February 2020.
  35. ↑ "Products". cslbehring.com.au. Retrieved 7 February 2020.
  36. ↑ Global product portfolio CSL Behring, 3 November 2010
  37. ↑ "CSL wins equal opportunity award for onsite childcare centre". CSL Newsroom. CSL. Retrieved 25 October 2016.

Sources

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